Regulatory Oversight, Proposed Rules, Pharmaceutical Industry

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on 6/25/2025

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on 1/22/2025

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on 5/9/2024

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

Bass, Berry & Sims PLC on 5/7/2024

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

Hogan Lovells on 3/13/2019

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally...more

CMS proposes requiring drug prices in TV ads

Hogan Lovells on 10/24/2018

On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or...more

TV Drug Commercials Must Disclose the Drug's List Price if HHS Adopts Proposed Rule

Akerman LLP - Health Law Rx on 10/19/2018

We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them....more

Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

Hogan Lovells on 6/19/2018

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject...more

FDA proposes streamlining combination product regulations

Hogan Lovells on 5/31/2018

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

Regulatory Oversight › Proposed Rules › Pharmaceutical Industry

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